Removal of a MEDICAL DEVICE from the market due to a problem occurring in the manufacture or distribution of the product.
Expendable and nonexpendable equipment, supplies, apparatus, and instruments that are used in diagnostic, surgical, therapeutic, scientific, and experimental procedures.
Process that is gone through in order for a device to receive approval by a government regulatory agency. This includes any required preclinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance. It is not restricted to FDA.
Freedom of equipment from actual or potential hazards.
Laws and regulations pertaining to devices used in medicine, proposed for enactment, or enacted by a legislative body.
An agency of the PUBLIC HEALTH SERVICE concerned with the overall planning, promoting, and administering of programs pertaining to maintaining standards of quality of foods, drugs, therapeutic devices, etc.
The process whereby a representation of past experience is elicited.